Section of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH 03756, USA.
J Vasc Surg. 2010 Mar;51(3):559-64, 564.e1. doi: 10.1016/j.jvs.2009.10.078. Epub 2010 Jan 4.
Controversy persists regarding the use of protamine during carotid endarterectomy (CEA) based on prior conflicting reports documenting both reduced bleeding as well as increased stroke risk. The purpose of this study was to determine the effect of protamine reversal of heparin anticoagulation on the outcome of CEA in a contemporary multistate registry.
We reviewed a prospective regional registry of 4587 CEAs in 4311 patients performed by 66 surgeons from 11 centers in Northern New England from 2003-2008. Protamine use varied by surgeon (38% routine use, 44% rare use, 18% selective use). Endpoints were postoperative bleeding requiring reoperation as well as potential thrombotic complications, including stroke, death, and myocardial infarction (MI). Predictors of endpoints were determined by multivariate logistic regression after associated variables were identified by univariate analysis.
Of the 4587 CEAs performed, 46% utilized protamine, while 54% did not. Fourteen patients (0.64%) in the protamine-treated group required reoperation for bleeding compared with 42 patients (1.66%) in the untreated cohort (P = .001). Protamine use did not affect the rate of MI (1.1% vs 0.91%, P = .51), stroke (0.78% vs 1.15%, P = .2), or death (0.23% vs 0.32%, P = .57) between treated and untreated patients, respectively. By multivariate analysis, protamine (odds ratio [OR] 0.32, 95% confidence interval [CI], 0.17-0.63; P = .001) and patch angioplasty (OR 0.46, 95% CI, 0.26-0.81; P = .007) were independently associated with diminished reoperation for bleeding. A single center was associated with a significantly higher rate of reoperation for bleeding (OR 6.47, 95% CI, 3.02-13.9; P < .001). Independent of protamine use, consequences of reoperation for bleeding were significant, with a four-fold increase in MI, a seven-fold increase in stroke, and a 30-fold increase in death.
Protamine reduced serious bleeding requiring reoperation during CEA without increasing the risk of MI, stroke, or death, in this large, contemporary registry. In light of significant complications referable to bleeding, liberal use of protamine during CEA appears warranted.
基于先前相互矛盾的报告既记录了出血减少，又记录了中风风险增加，因此在颈动脉内膜切除术（CEA）中使用鱼精蛋白仍然存在争议。本研究的目的是在一个当代多州注册中心确定鱼精蛋白逆转肝素抗凝对 CEA 结果的影响。
我们回顾了 2003 年至 2008 年间，来自新英格兰北部 11 个中心的 66 位外科医生对 4311 名患者进行的 4587 例 CEA 的前瞻性区域注册。外科医生使用鱼精蛋白的情况各不相同（常规使用 38%，罕见使用 44%，选择性使用 18%）。术后出血需要再次手术的终点，以及潜在的血栓并发症，包括中风、死亡和心肌梗死（MI）。通过单变量分析确定相关变量后，使用多变量逻辑回归确定终点的预测因素。
在进行的 4587 例 CEA 中，46%使用了鱼精蛋白，而 54%未使用。在接受鱼精蛋白治疗的组中，有 14 名患者（0.64%）因出血需要再次手术，而在未接受治疗的组中，有 42 名患者（1.66%）需要再次手术（P=0.001）。鱼精蛋白的使用并未影响 MI 的发生率（1.1% vs 0.91%，P=0.51）、中风（0.78% vs 1.15%，P=0.2）或死亡（0.23% vs 0.32%，P=0.57）。多变量分析显示，鱼精蛋白（比值比[OR]0.32，95%置信区间[CI]0.17-0.63；P=0.001）和补片血管成形术（OR 0.46，95%CI 0.26-0.81；P=0.007）与出血再次手术减少独立相关。单一中心与出血再次手术率显著升高相关（OR 6.47，95%CI 3.02-13.9；P<0.001）。独立于鱼精蛋白的使用，再次手术出血的后果是显著的，MI 增加了四倍，中风增加了七倍，死亡增加了三十倍。
在这个大型的当代注册中心，鱼精蛋白减少了 CEA 期间需要再次手术的严重出血，而不会增加 MI、中风或死亡的风险。鉴于与出血相关的严重并发症，在 CEA 期间大量使用鱼精蛋白似乎是合理的。
